ID

2209

Description

Form 1 - Eligibility Checklist and Initial Evaluation Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/22/15 3/22/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00049543 On-Study - Form 1 - Eligibility Checklist and Initial Evaluation - 2055363v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Form 1 - Eligibility Checklist and Initial Evaluation
    1. No Instruction available.
Patient Information
Description

Patient Information

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Gender
Description

PatientGender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Institution Name
Description

InstitutionName

Data type

text

Registered Investigator (NCI Investigator #)
Description

RegisteredInvestigator

Data type

text

Patient's Date of Birth (yyyy mmm dd)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient Race (check _ all that apply)
Description

PatientRace

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Patient Ethnicity (check _ one only)
Description

PatientEthnicity

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Payment Method (check _ one USA only)
Description

PaymentMethod

Data type

text

IRB/REB Approval Date (yyyy mmm dd)
Description

IRBApprovalDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Projected Start Date of Treatment (yyyy mmm dd)
Description

ProjectedTreatmentBeginDate

Data type

date

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Logged
Description

LoggedEntryInitials

Data type

text

Unnamed (Logged Date)
Description

LoggedEntryDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
RA
Description

RegulatoryAffairsReviewInitials

Data type

text

Unnamed (RA Date)
Description

RegulatoryAffairsReviewDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Study Coord
Description

CoordinatorReviewInitials

Data type

text

Unnamed (Coord Date)
Description

CoordinatorReviewDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Phy
Description

PhysicianReviewInitials

Data type

text

Data Ent'd
Description

DataEntryInitials

Data type

text

Verified
Description

DataVerificationInitials

Data type

text

Unnamed1
Description

Unnamed1

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Eligibility Checklist
Description

Eligibility Checklist

Patient has histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete radiological mass or node are eligible. Please specify)
Description

LungCancerProofInd

Data type

text

Histologic Type
Description

HistologicType

Data type

text

Post operatively the patient had a pathological stage of
Description

PathologicStagePostoperativeInd

Data type

text

Stage
Description

StageGrouping

Data type

text

Adequate Lymph Node sampling was performed (see section 5.1.1.4 of the protocol)
Description

LymphNodeAdequateSamplingInd

Data type

text

Please specify the extent of lymph node sampling (check _ one only)
Description

LymphNodeSamplingExtent

Data type

text

Nodes >= 1.5 cm were sampled (specify)
Description

LymphNodeSamplingExtentLargeSite

Data type

text

Other (specify)
Description

LymphNodeSamplingOtherExtent

Data type

text

Surgery consisted of lobectomy, sleeve resection, bilobectomy or pneumonectomy. (segmentectomy or wedge resection only is not eligible)
Description

LungCarcinomaSurgicalProcedureTherapyInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus ObjectClass
C4878
UMLS 2011AA ObjectClass
C0684249
Patient has had all gross disease surgically removed.
Description

GrossDiseaseRemovedInd

Data type

text

All surgical margins of resection are negative for tumour.
Description

SurgicalResectionNegativeMarginIndicator

Data type

text

No more than 16 weeks may have elapsed between surgical resection and randomization.
Description

MaximumTimePostSurgeryIndicator

Data type

text

Surgery Date (yyyy mmm dd)
Description

SurgeryDate

Data type

date

A representative formalin fixed paraffin block of tumour tissue must be submitted at the request of the central tumour bank in order that specific EGFR correlative marker assays may be conducted.
Description

TumorBlocksSentIndicator

Data type

text

Performance Status is <= 2. (see protocol appendix II)
Description

MinimumPerformanceStatusIndicator

Data type

text

Required hematologic and biochemistry investigations done within 14 days prior to randomization, including:
Description

RequiredHematology14DaysIndicator

Data type

text

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Peripheral WBC Count (1000/uL or x 10 9/L)
Description

Lab,Hematology,WBC

Data type

double

Peripheral neutrophil count (>= 1.5 x 10 9/L or >= 1500/uL; Value)
Description

Lab,Hematology,NeutrophilCount

Data type

double

Peripheral Platelet Count (1000/uL or x 10 9/L)
Description

Lab,Hematology,Platelets

Data type

double

Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Patient Gender
Description

PatientGender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Histologic Type
Description

HistologicType

Data type

text

Stage
Description

StageGrouping

Data type

text

Unnamed2
Description

Unnamed2

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Eligibility Checklist Continued
Description

Eligibility Checklist Continued

Specimen Collection Date (Biochemistry, yyyy mmm dd)
Description

SpecimenCollectionDate

Data type

date

Required biochemistry investigations done within 14 days prior to randomization, and greater than 8 days following surgical resection, including
Description

RequiredBiochemistry14DaysIndicator

Data type

text

Bilirubin (uL or 10 9/L)
Description

Lab,Hepatic,Bilirubin

Data type

double

Bilirubin ULN
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
Description

AdjuvantRTEndDate

Data type

date

SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGOT

Data type

double

SGOT (AST) ULN
Description

SGOTLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGPT

Data type

double

SGPT (ALT) ULN
Description

SGPTLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

double

Alkaline Phosphatase ULN
Description

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Creatinine (mg/dl or umol/L)
Description

Lab,Renal,Creatinine

Data type

double

Creatinine ULN
Description

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Patient's age is >= 18 years (lower age limit subject to local policy regarding age at which patient may sign own consent)
Description

PatientAge18YearsIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has had a chest x-ray within 14 days of randomization.
Description

PrestudyChestX-RayIndicator

Data type

text

Date of chest x-ray (yyyy mmm dd)
Description

ChestX-RayAssessmentDate

Data type

date

Patient has had a CT or MRI scan of the chest within 42 days prior to surgery.
Description

PrestudyChestCTIndicator

Data type

text

Date of CT or MRI of chest (yyyy mmm dd)
Description

ChestComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus ObjectClass
C25389
UMLS 2011AA ObjectClass
C0817096
NCI Thesaurus ObjectClass
C16809
UMLS 2011AA ObjectClass
C0024485
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient has had an EKG within 14 days prior to randomization.
Description

PrestudyEKGIndicator

Data type

text

Date of EKG (yyyy mmm dd)
Description

DiagnosticElectrocardiogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Men and women of childbearing age will use adequate contraception.
Description

EligibilityContraceptionIndicator

Data type

text

Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)
Description

PrestudyPostoperativeRadiationTherapyIndicator

Data type

text

Radiation therapy has been completed at least three weeks prior to randomization
Description

PrestudyRadiationTherapyCompleteIndicator

Data type

text

The patient has recovered from all radiation therapy related toxicity
Description

RadiationTherapyToxicityRecoveryIndicator

Data type

text

Informed consent has been signed and dated by patient.
Description

PatientConsentSignedIndicator

Data type

text

Date informed consent signed (yyyy mmm dd)
Description

InformedConsentDateSigned

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient accessible for treatment and follow-up.
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Initiation of protocol therapy will begin within 10 working days of randomization.
Description

TreatmentRequirementBeginIndicator

Data type

text

Ncic Ctg Use Only2
Description

Ncic Ctg Use Only2

Post-operative radiotherapy
Description

PostoperativeRadiotherapyStatus

Data type

text

Unnamed3
Description

Unnamed3

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Eligibility Checklist Continued2
Description

Eligibility Checklist Continued2

No other prior or concurrent malignancies within the last 5 years, except as specified in protocol section 5.2.1.
Description

NoOtherMalignancyIndicator

Data type

text

No combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumour.
Description

NoCombinationLungCancerIndicator

Data type

text

No more than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB are ineligible)
Description

OneDiscretePrimaryCancerIndicator

Data type

text

No clinically significant or untreated ophthalmologic or gastrointestinal conditions.
Description

NoOphthalmologicGastrointestinalDiseaseIndicator

Data type

text

No active pathological condition that would render the protocol treatment dangerous. (see protocol section 5.2.5 )
Description

NoPathologicRiskConditionIndicator

Data type

text

No history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic, or that would limit compliance with study requirements.
Description

NoPsychiatricImpairmentHistoryIndicator

Data type

text

Patient, if female, is not pregnant or breast feeding.
Description

FemalePatientNotPregnantIndicator

Data type

text

No prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC. (limited low dose preoperative radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction is permitted, however full dose, pre-operative radiotherapy of curative intent is cause for exclusion )
Description

NoPriorLungChemotherapyIndicator

Data type

text

No history of allergic reactions to compounds of similar chemical or biologic composition to IRESSA.
Description

NoAgentAllergyHistoryIndicator

Data type

text

Patient does not take drugs which induce CYP3A4 enzymes, e.g., phenytoin, carbamazepine, barbiturates, rifampicin or St John's Wort.
Description

NoCYP3A4EnzymeMedicationsIndicator

Data type

text

Adequate healing from previous oncologic or other major surgery has occurred.
Description

AdequateSurgicalHealingIndicator

Data type

text

Randomization
Description

Randomization

Randomization Date (yyyy mmm dd)
Description

RandomizationDate

Data type

date

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Date of Investigator Signature (yyyy mmm dd)
Description

InvestigatorSignatureDate

Data type

date

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form Completion Date, Original (yyyy mmm dd)
Description

FormCompletionDate,Original

Data type

date

Unnamed4
Description

Unnamed4

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
History And Physical Exam
Description

History And Physical Exam

Is patient currently smoking?
Description

PatientCurrentSmokerIndicator

Data type

text

Date of evaluation (yyyy mmm dd)
Description

AssessmentDate

Data type

date

Has previously been a smoker?
Description

PatientPreviousSmokerIndicator

Data type

text

Performance Status (check _ one)
Description

PerformanceStatus

Data type

text

Patient Height (cm)
Description

PatientHeight

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Patient Weight (kg)
Description

PatientWeight

Data type

double

Investigations
Description

Investigations

Imaging Site
Description

DiagnosticImagingAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
Method of Evaluation
Description

AssessmentType

Data type

text

Date of evaluation (yyyy mmm dd)
Description

AssessmentDate

Data type

date

Pregnancy test
Description

PregnancyTestResult

Data type

text

Unnamed5
Description

Unnamed5

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Baseline Hematology/biochemistry Values
Description

Baseline Hematology/biochemistry Values

Hemoglobin (g/dl or g/L)
Description

Lab,Hematology,Hemoglobin

Data type

double

Peripheral Neutrophils (%)
Description

Lab,Hematology,Neutrophils,CellPercentage

Data type

double

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Peripheral WBC Count (1000/uL or x 10 9/L)
Description

Lab,Hematology,WBC

Data type

double

Peripheral Platelet Count (1000/uL or x 10 9/L)
Description

Lab,Hematology,Platelets

Data type

double

Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Biochemistry
Description

Biochemistry

Specimen Collection Date (Biochemistry, yyyy mmm dd)
Description

SpecimenCollectionDate

Data type

date

Bilirubin (uL or 10 9/L)
Description

Lab,Hepatic,Bilirubin

Data type

double

Bilirubin ULN
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGOT

Data type

double

SGOT (AST) ULN
Description

SGOTLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGPT

Data type

double

SGPT (ALT) ULN
Description

SGPTLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

double

Alkaline Phosphatase ULN
Description

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Lactate Dehydrogenase (LDH) (U/L)
Description

Lab,Chemistry,LactateDehydrogenase

Data type

double

Lactate Dehydrogenase ULN
Description

Lab,Chemistry,LactateDehydrogenase,ULN

Data type

double

Creatinine (mg/dl or umol/L)
Description

Lab,Renal,Creatinine

Data type

double

Creatinine ULN
Description

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
BUN (mg/dl or umol/L)
Description

Lab,Renal,BUN

Data type

double

BUN ULN
Description

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C61019
UMLS 2011AA Property
C0005845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Potassium (K) (mEq/L)
Description

Lab,Electrolytes,Potassium

Data type

double

Potassium LLN
Description

LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus Property
C765
UMLS 2011AA Property
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Potassium ULN
Description

LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus Property
C765
UMLS 2011AA Property
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Sodium (Na) (mmol/L)
Description

Lab,Electrolytes,Sodium

Data type

double

Sodium LLN
Description

LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C830
UMLS 2011AA Property
C0037473
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Sodium ULN
Description

LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C830
UMLS 2011AA Property
C0037473
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Chloride (Cl) (mEq/L)
Description

Lab,Electrolytes,Chloride

Data type

double

Chloride LLN
Description

LaboratoryProcedureChlorideIonElectrolytesOutcomeLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus Property
C1741
UMLS 2011AA Property
C0596019
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Chloride ULN
Description

LaboratoryProcedureChlorideIonElectrolytesOutcomeUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus Property
C1741
UMLS 2011AA Property
C0596019
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Calcium (Ca) (mg/dL or umol/L)
Description

Lab,Electrolytes,Calcium

Data type

double

Calcium LLN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Calcium ULN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Albumin (g/dl or g/L)
Description

Chemistry,BloodAlbumin

Data type

double

Albumin LLN
Description

LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C214
UMLS 2011AA Property
C0001924
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Albumin ULN
Description

LaboratoryProcedureAlbuminResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C214
UMLS 2011AA Property
C0001924
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Unnamed6
Description

Unnamed6

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Disease History/prior Treatment
Description

Disease History/prior Treatment

Primary Surgery Date (yyyy mmm dd)
Description

PrimarySurgeryDate

Data type

date

N Stage, Pathologic (check _ one)
Description

NStage,Pathologic

Data type

text

Histologic Type
Description

HistologicType

Data type

text

T Stage, Pathologic (check _ one)
Description

TStage,Pathologic

Data type

text

Stage Grouping, Pathologic
Description

StageGrouping,Pathologic

Data type

text

Specify other histologic type
Description

HistologicType,OtherName

Data type

text

Histologic Grade (WHO)
Description

HistologicGrade

Data type

text

Is there vascular invasion?
Description

VascularInvasionInd

Data type

text

Is the parietal pleural margin involved?
Description

ParietalPleuralMarginInvolvedInd

Data type

text

Was lymph node sampling done?
Description

LymphNodeSamplingInd

Data type

text

Number of Lymph Nodes Examined (If yes,)
Description

LymphNode(s)ExaminedNumber

Data type

double

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Number of Positive Lymph Nodes
Description

LymphNode(s)PositiveNumber

Data type

double

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Lymph Nodes Type (Station)
Description

LymphNodesType

Data type

text

Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
Description

LymphNodeInvolvement

Data type

text

Unnamed7
Description

Unnamed7

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Disease History/prior Treatment Continued
Description

Disease History/prior Treatment Continued

Type of Procedure
Description

SurgicalProcedureType

Data type

text

Tumour Size, Maximum Diameter (cm Record longest or largest diameter of tumour.)
Description

TumorSize,MaximumDiameter

Data type

double

Tumour Location, Side
Description

TumorLocation,Side

Data type

text

Tumour Location, Area (check _ all that apply)
Description

TumorLocation,Area

Data type

text

Other, specify
Description

TumorLocation,AreaOther

Data type

text

Tumour Location, Zone (check _ all that apply)
Description

TumorLocation,Zone

Data type

text

Does the tumour involve the pleura?
Description

PleuraInvolvedInd

Data type

text

Is the tumour at the surgical margin?
Description

TumorMarginInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25563
UMLS 2011AA Property
C0205284
Tumour Extension (check _ all that apply)
Description

TumorExtension

Data type

text

Other, specify
Description

TumorExtension,OtherStructures

Data type

text

Prior Treatment
Description

Prior Treatment

Prior adjuvant RT? (If yes, record below)
Description

PriorAdjuvantRTInd

Data type

text

Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
Description

AdjuvantRTBeginDate

Data type

date

Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
Description

AdjuvantRTEndDate

Data type

date

Total dose of Radiation Therapy (cGy)
Description

RTTotalDose

Data type

double

Prior Adjuvant Chemotherapy?
Description

PriorAdjuvantChemotherapyInd

Data type

text

Unnamed8
Description

Unnamed8

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Baseline Symptoms/"toxicity" Status
Description

Baseline Symptoms/"toxicity" Status

COMMENTS
Description

Comments

Data type

text

CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
Description

CTCAdverseEventTerm

Data type

text

CTC Adverse Event Term, Other
Description

CTCAdverseEventTerm,Other

Data type

text

CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventCategory

Data type

text

CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventGrade

Data type

text

Concomitant Medications
Description

Concomitant Medications

Agent Name (generic or trade name)
Description

AgentName

Data type

text

Unnamed9
Description

Unnamed9

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Other Major Medical Problems
Description

Other Major Medical Problems

Date Documented (yyyy mmm dd)
Description

PatientMedicalConditionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Condition (e.g. diabetes)
Description

PatientMedicalConditionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other Relevant Details (e.g. insulin treatment)
Description

PatientHistoryText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Comments
Description

Comments

COMMENTS
Description

Comments

Data type

text

Investigator Signature
Description

Investigator Signature

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form Completion Date, Original (yyyy mmm dd)
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Form 1 - Eligibility Checklist And Initial Evaluation
Description

Ccrr Module For Form 1 - Eligibility Checklist And Initial Evaluation

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1 forms
  1. StudyEvent: Form 1 - Eligibility Checklist and Initial Evaluation
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.9
Code List
Patient Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InstitutionName
Item
Institution Name
text
RegisteredInvestigator
Item
Registered Investigator (NCI Investigator #)
text
PatientBirthDate
Item
Patient's Date of Birth (yyyy mmm dd)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Patient Race (check _ all that apply)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.2
Code List
Patient Race (check _ all that apply)
CL Item
White_cdus (White)
CL Item
Black_cdus (Black or African American)
CL Item
Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)
CL Item
Asian_cdus (Asian)
CL Item
Native_american_cdus (American Indian or Alaska Native)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Patient Ethnicity (check _ one only)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.3
Code List
Patient Ethnicity (check _ one only)
CL Item
Hispanic_or_latino (Hispanic or Latino)
CL Item
Non_hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Payment Method (check _ one USA only)
text
CL.4
Code List
Payment Method (check _ one USA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare/Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid & Medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS and TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self pay (no insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
IRBApprovalDate
Item
IRB/REB Approval Date (yyyy mmm dd)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
ProjectedTreatmentBeginDate
Item
Projected Start Date of Treatment (yyyy mmm dd)
date
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Unnamed (Logged Date)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
RegulatoryAffairsReviewInitials
Item
RA
text
RegulatoryAffairsReviewDate
Item
Unnamed (RA Date)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Unnamed (Coord Date)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PhysicianReviewInitials
Item
Phy
text
DataEntryInitials
Item
Data Ent'd
text
DataVerificationInitials
Item
Verified
text
Item Group
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Eligibility Checklist
LungCancerProofInd
Item
Patient has histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete radiological mass or node are eligible. Please specify)
text
Item
Histologic Type
text
CL.27
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Adenosquamous Carcinoma (Adenosquamous carcinoma)
CL Item
Large Cell Undifferentiated (Large cell undifferentiated)
CL Item
Other, Specify (Other)
PathologicStagePostoperativeInd
Item
Post operatively the patient had a pathological stage of
text
Item
Stage
text
CL.11
Code List
Stage
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IB)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (II)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IIIA)
LymphNodeAdequateSamplingInd
Item
Adequate Lymph Node sampling was performed (see section 5.1.1.4 of the protocol)
text
Item
Please specify the extent of lymph node sampling (check _ one only)
text
CL.7
Code List
Please specify the extent of lymph node sampling (check _ one only)
CL Item
Complete Mediastinal Resection (Complete mediastinal resection)
CL Item
Partial Mediastinal Resection (Partial mediastinal resection)
CL Item
Nodes >= 1.5 Cm Were Sampled (Nodes >= 1.5 cm were sampled)
CL Item
No Enlarged Lymph Nodes On Ct Chest, No Mediastinal Sampling Done (No enlarged lymph nodes on CT chest, no mediastinal sampling done)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LymphNodeSamplingExtentLargeSite
Item
Nodes >= 1.5 cm were sampled (specify)
text
LymphNodeSamplingOtherExtent
Item
Other (specify)
text
LungCarcinomaSurgicalProcedureTherapyInd-3
Item
Surgery consisted of lobectomy, sleeve resection, bilobectomy or pneumonectomy. (segmentectomy or wedge resection only is not eligible)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C4878 (NCI Thesaurus ObjectClass)
C0684249 (UMLS 2011AA ObjectClass)
GrossDiseaseRemovedInd
Item
Patient has had all gross disease surgically removed.
text
SurgicalResectionNegativeMarginIndicator
Item
All surgical margins of resection are negative for tumour.
text
MaximumTimePostSurgeryIndicator
Item
No more than 16 weeks may have elapsed between surgical resection and randomization.
text
SurgeryDate
Item
Surgery Date (yyyy mmm dd)
date
TumorBlocksSentIndicator
Item
A representative formalin fixed paraffin block of tumour tissue must be submitted at the request of the central tumour bank in order that specific EGFR correlative marker assays may be conducted.
text
MinimumPerformanceStatusIndicator
Item
Performance Status is <= 2. (see protocol appendix II)
text
RequiredHematology14DaysIndicator
Item
Required hematologic and biochemistry investigations done within 14 days prior to randomization, including:
text
Lab,Hematology,SampleCollectionDate
Item
Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
date
Lab,Hematology,WBC
Item
Peripheral WBC Count (1000/uL or x 10 9/L)
double
Lab,Hematology,NeutrophilCount
Item
Peripheral neutrophil count (>= 1.5 x 10 9/L or >= 1500/uL; Value)
double
Lab,Hematology,Platelets
Item
Peripheral Platelet Count (1000/uL or x 10 9/L)
double
Item
Lab Unit of Measure (circle unit used)
text
CL.23
Code List
Lab Unit of Measure (circle unit used)
CL Item
Ul (uL)
CL Item
X10^9/l (10 9/L)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dl)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dL)
CL Item
G/l (g/L)
Item Group
Ncic Ctg Use Only
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.9
Code List
Patient Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
Item
Histologic Type
text
CL.27
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Adenosquamous Carcinoma (Adenosquamous carcinoma)
CL Item
Large Cell Undifferentiated (Large cell undifferentiated)
CL Item
Other, Specify (Other)
Item
Stage
text
CL.11
Code List
Stage
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IB)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (II)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IIIA)
Item Group
Unnamed2
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Eligibility Checklist Continued
SpecimenCollectionDate
Item
Specimen Collection Date (Biochemistry, yyyy mmm dd)
date
RequiredBiochemistry14DaysIndicator
Item
Required biochemistry investigations done within 14 days prior to randomization, and greater than 8 days following surgical resection, including
text
Lab,Hepatic,Bilirubin
Item
Bilirubin (uL or 10 9/L)
double
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
AdjuvantRTEndDate
Item
Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
date
Lab,Hepatic,SGOT
Item
SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
double
SGOTLabUpperLimitNormalValue
Item
SGOT (AST) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGPT
Item
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
double
SGPTLabUpperLimitNormalValue
Item
SGPT (ALT) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
double
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Renal,Creatinine
Item
Creatinine (mg/dl or umol/L)
double
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
PatientAge18YearsIndicator
Item
Patient's age is >= 18 years (lower age limit subject to local policy regarding age at which patient may sign own consent)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PrestudyChestX-RayIndicator
Item
Patient has had a chest x-ray within 14 days of randomization.
text
ChestX-RayAssessmentDate
Item
Date of chest x-ray (yyyy mmm dd)
date
PrestudyChestCTIndicator
Item
Patient has had a CT or MRI scan of the chest within 42 days prior to surgery.
text
ChestComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedDate
Item
Date of CT or MRI of chest (yyyy mmm dd)
date
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C16809 (NCI Thesaurus ObjectClass)
C0024485 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PrestudyEKGIndicator
Item
Patient has had an EKG within 14 days prior to randomization.
text
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
Item
Lab Unit of Measure (circle unit used)
text
CL.23
Code List
Lab Unit of Measure (circle unit used)
CL Item
Ul (uL)
CL Item
X10^9/l (10 9/L)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dl)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dL)
CL Item
G/l (g/L)
EligibilityContraceptionIndicator
Item
Men and women of childbearing age will use adequate contraception.
text
Item
Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)
text
CL.13
Code List
Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PrestudyRadiationTherapyCompleteIndicator
Item
Radiation therapy has been completed at least three weeks prior to randomization
text
RadiationTherapyToxicityRecoveryIndicator
Item
The patient has recovered from all radiation therapy related toxicity
text
PatientConsentSignedIndicator
Item
Informed consent has been signed and dated by patient.
text
InformedConsentDateSigned
Item
Date informed consent signed (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Patient accessible for treatment and follow-up.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TreatmentRequirementBeginIndicator
Item
Initiation of protocol therapy will begin within 10 working days of randomization.
text
Item Group
Ncic Ctg Use Only2
Item
Post-operative radiotherapy
text
CL.14
Code List
Post-operative radiotherapy
CL Item
Given (Given)
CL Item
Not Given (Not given)
Item Group
Unnamed3
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Eligibility Checklist Continued2
NoOtherMalignancyIndicator
Item
No other prior or concurrent malignancies within the last 5 years, except as specified in protocol section 5.2.1.
text
NoCombinationLungCancerIndicator
Item
No combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumour.
text
OneDiscretePrimaryCancerIndicator
Item
No more than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB are ineligible)
text
NoOphthalmologicGastrointestinalDiseaseIndicator
Item
No clinically significant or untreated ophthalmologic or gastrointestinal conditions.
text
NoPathologicRiskConditionIndicator
Item
No active pathological condition that would render the protocol treatment dangerous. (see protocol section 5.2.5 )
text
NoPsychiatricImpairmentHistoryIndicator
Item
No history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic, or that would limit compliance with study requirements.
text
Item
Patient, if female, is not pregnant or breast feeding.
text
CL.15
Code List
Patient, if female, is not pregnant or breast feeding.
CL Item
Na (NA)
NoPriorLungChemotherapyIndicator
Item
No prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC. (limited low dose preoperative radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction is permitted, however full dose, pre-operative radiotherapy of curative intent is cause for exclusion )
text
NoAgentAllergyHistoryIndicator
Item
No history of allergic reactions to compounds of similar chemical or biologic composition to IRESSA.
text
NoCYP3A4EnzymeMedicationsIndicator
Item
Patient does not take drugs which induce CYP3A4 enzymes, e.g., phenytoin, carbamazepine, barbiturates, rifampicin or St John's Wort.
text
AdequateSurgicalHealingIndicator
Item
Adequate healing from previous oncologic or other major surgery has occurred.
text
Item Group
Randomization
RandomizationDate
Item
Randomization Date (yyyy mmm dd)
date
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
InvestigatorSignatureDate
Item
Date of Investigator Signature (yyyy mmm dd)
date
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
Unnamed4
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
History And Physical Exam
Item
Is patient currently smoking?
text
CL.16
Code List
Is patient currently smoking?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
AssessmentDate
Item
Date of evaluation (yyyy mmm dd)
date
Item
Has previously been a smoker?
text
CL.17
Code List
Has previously been a smoker?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Performance Status (check _ one)
text
CL.18
Code List
Performance Status (check _ one)
CL Item
0 (0 = Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (1 = Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (2 = Ambulatory and capable of all self-care but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (4 = Completely disabled, cannot carry on any self-care. Totally confined to bed or chair (K 10-20))
PatientHeight
Item
Patient Height (cm)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Patient Weight (kg)
double
Item Group
Investigations
Item
Imaging Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
CL.19
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Abdomen (Abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Cardiac (Cardiac)
C13306 (NCI Thesaurus)
C1522601 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.20
Code List
Method of Evaluation
CL Item
Chest X-ray (Chest x-ray)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Ekg (EKG)
CL Item
Not Evaluated (Not evaluated)
AssessmentDate
Item
Date of evaluation (yyyy mmm dd)
date
Item
Pregnancy test
text
CL.21
Code List
Pregnancy test
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
Item Group
Unnamed5
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Baseline Hematology/biochemistry Values
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl or g/L)
double
Lab,Hematology,Neutrophils,CellPercentage
Item
Peripheral Neutrophils (%)
double
Lab,Hematology,SampleCollectionDate
Item
Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
date
Lab,Hematology,WBC
Item
Peripheral WBC Count (1000/uL or x 10 9/L)
double
Lab,Hematology,Platelets
Item
Peripheral Platelet Count (1000/uL or x 10 9/L)
double
Item
Lab Unit of Measure (circle unit used)
text
CL.23
Code List
Lab Unit of Measure (circle unit used)
CL Item
Ul (uL)
CL Item
X10^9/l (10 9/L)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dl)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dL)
CL Item
G/l (g/L)
Item Group
Biochemistry
SpecimenCollectionDate
Item
Specimen Collection Date (Biochemistry, yyyy mmm dd)
date
Lab,Hepatic,Bilirubin
Item
Bilirubin (uL or 10 9/L)
double
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGOT
Item
SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
double
SGOTLabUpperLimitNormalValue
Item
SGOT (AST) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGPT
Item
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
double
SGPTLabUpperLimitNormalValue
Item
SGPT (ALT) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
double
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Chemistry,LactateDehydrogenase
Item
Lactate Dehydrogenase (LDH) (U/L)
double
Lab,Chemistry,LactateDehydrogenase,ULN
Item
Lactate Dehydrogenase ULN
double
Lab,Renal,Creatinine
Item
Creatinine (mg/dl or umol/L)
double
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Renal,BUN
Item
BUN (mg/dl or umol/L)
double
LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue
Item
BUN ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property)
C0005845 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Electrolytes,Potassium
Item
Potassium (K) (mEq/L)
double
LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue
Item
Potassium LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C765 (NCI Thesaurus Property)
C0032821 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue
Item
Potassium ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C765 (NCI Thesaurus Property)
C0032821 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Electrolytes,Sodium
Item
Sodium (Na) (mmol/L)
double
LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue
Item
Sodium LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property)
C0037473 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Item
Lab Unit of Measure (circle unit used)
text
CL.23
Code List
Lab Unit of Measure (circle unit used)
CL Item
Ul (uL)
CL Item
X10^9/l (10 9/L)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dl)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dL)
CL Item
G/l (g/L)
LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue
Item
Sodium ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property)
C0037473 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Electrolytes,Chloride
Item
Chloride (Cl) (mEq/L)
double
LaboratoryProcedureChlorideIonElectrolytesOutcomeLowerLimitofNormalValue
Item
Chloride LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C1741 (NCI Thesaurus Property)
C0596019 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureChlorideIonElectrolytesOutcomeUpperLimitofNormalValue
Item
Chloride ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C1741 (NCI Thesaurus Property)
C0596019 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Electrolytes,Calcium
Item
Calcium (Ca) (mg/dL or umol/L)
double
LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
Item
Calcium LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
Item
Calcium ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Chemistry,BloodAlbumin
Item
Albumin (g/dl or g/L)
double
LaboratoryProcedureAlbuminResultLowerLimitofNormalValue
Item
Albumin LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlbuminResultUpperLimitNormalValue
Item
Albumin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item Group
Unnamed6
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Disease History/prior Treatment
PrimarySurgeryDate
Item
Primary Surgery Date (yyyy mmm dd)
date
Item
N Stage, Pathologic (check _ one)
text
CL.24
Code List
N Stage, Pathologic (check _ one)
CL Item
N0, According To Ajcc Criteria (N0)
CL Item
N1, According To Ajcc Criteria (N1)
CL Item
N2, According To Ajcc Criteria (N2)
CL Item
N3, According To Ajcc Criteria (N3)
CL Item
Nx, According To Ajcc Criteria (Nx)
Item
Histologic Type
text
CL.27
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Adenosquamous Carcinoma (Adenosquamous carcinoma)
CL Item
Large Cell Undifferentiated (Large cell undifferentiated)
CL Item
Other, Specify (Other)
Item
T Stage, Pathologic (check _ one)
text
CL.25
Code List
T Stage, Pathologic (check _ one)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct (T4)
Item
Stage Grouping, Pathologic
text
CL.26
Code List
Stage Grouping, Pathologic
CL Item
Ib, According To Current Ajcc Guidelines (IB)
CL Item
Iia, According To Current Ajcc Guidelines (IIA)
CL Item
Iib, According To Current Ajcc Guidelines (IIB)
CL Item
Iiia, According To Current Ajcc Guidelines (IIIA)
HistologicType,OtherName
Item
Specify other histologic type
text
Item
Histologic Grade (WHO)
text
CL.28
Code List
Histologic Grade (WHO)
CL Item
Well Differentiated (Grade I)
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderate (Grade II)
CL Item
Poor (Grade III)
Item
Is there vascular invasion?
text
CL.29
Code List
Is there vascular invasion?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is the parietal pleural margin involved?
text
CL.30
Code List
Is the parietal pleural margin involved?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Was lymph node sampling done?
text
CL.31
Code List
Was lymph node sampling done?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LymphNode(s)ExaminedNumber
Item
Number of Lymph Nodes Examined (If yes,)
double
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
LymphNode(s)PositiveNumber
Item
Number of Positive Lymph Nodes
double
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
Item
Lymph Nodes Type (Station)
text
CL.32
Code List
Lymph Nodes Type (Station)
CL Item
Highest Mediastinal Node (Highest mediastinal (1))
CL Item
Right Upper Paratracheal Node (Right upper paratracheal (2R))
CL Item
Left Upper Paratracheal Node (Left upper paratracheal (2L))
CL Item
Pre- And Retro Paratracheal Node (Pre- and retro paratracheal (3))
CL Item
Right Lower Paratracheal Node (Right lower paratracheal (4R))
CL Item
Left Lower Paratracheal Node (Left lower paratracheal (4L))
CL Item
Subaortic Node (Subaortic (5))
CL Item
Para-aortic Node (Para-aortic (6))
CL Item
Subcarinal Node (Subcarinal (7))
CL Item
Paraesophageal (Paraesophageal (8))
C25344 (NCI Thesaurus)
C0475302 (UMLS 2011AA)
CL Item
Pulmonary Ligament (Pulmonary ligament (9))
C0225794 (NCI Metathesaurus)
CL Item
Right Hilar Node (Right hilar (10R))
CL Item
Left Hilar Node (Left hilar (10L))
CL Item
Interlobar Node (Interlobar (11))
CL Item
Right Lobar Node (Right lobar (12R))
CL Item
Left Lobar Node (Left lobar (12L))
CL Item
Right Segmental Node (Right segmental (13R))
CL Item
Left Segmental Node (Left segmental (13L))
CL Item
Right Subsegmental Node (Right subsegmental (14R))
CL Item
Left Subsegmental Node (Left subsegmental (14L))
Item
Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
text
CL.33
Code List
Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
CL Item
Not Evaluated (not evaluated)
CL Item
The Node Is Considered To Be Positive Based Upon Histological Evaluation. (pathologically positive)
CL Item
The Node Is Considered To Be Negative Based Upon Histological Evaluation. (pathologically negative)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed7
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Disease History/prior Treatment Continued
Item
Type of Procedure
text
CL.34
Code List
Type of Procedure
CL Item
Lobectomy (Lobectomy)
C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)
CL Item
Pneumonectomy (Pneumonectomy)
C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)
CL Item
Bilobectomy (Bilobectomy)
CL Item
Bronchial Sleeve Resection (Bronchial sleeve resection)
TumorSize,MaximumDiameter
Item
Tumour Size, Maximum Diameter (cm Record longest or largest diameter of tumour.)
double
Item
Tumour Location, Side
text
CL.35
Code List
Tumour Location, Side
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item
Tumour Location, Area (check _ all that apply)
text
CL.36
Code List
Tumour Location, Area (check _ all that apply)
CL Item
Upper Lobe (Upper lobe)
CL Item
Middle Lobe (Middle lobe)
CL Item
Lower Lobe (Lower lobe)
CL Item
Mainstem Bronchus (Mainstem bronchus)
CL Item
Carina (Carina)
C25264 (NCI Thesaurus)
C0225594 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
TumorLocation,AreaOther
Item
Other, specify
text
Item
Tumour Location, Zone (check _ all that apply)
text
CL.37
Code List
Tumour Location, Zone (check _ all that apply)
CL Item
Predominantly Central (Predominantly central)
CL Item
Predominantly Peripheral (Predominantly peripheral)
CL Item
Indeterminate (Indeterminate)
C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Does the tumour involve the pleura?
text
CL.38
Code List
Does the tumour involve the pleura?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is the tumour at the surgical margin?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
CL.39
Code List
Is the tumour at the surgical margin?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Tumour Extension (check _ all that apply)
text
CL.40
Code List
Tumour Extension (check _ all that apply)
CL Item
Chest Wall (Chest Wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Pericardium (Pericardium)
C13005 (NCI Thesaurus)
C0031050 (UMLS 2011AA)
CL Item
Mediastinum (Mediastinum)
C12748 (NCI Thesaurus)
C0025066 (UMLS 2011AA)
CL Item
Diaphragm (Diaphragm)
C12702 (NCI Thesaurus)
C0011980 (UMLS 2011AA)
CL Item
Esophagus (Esophagus)
C12389 (NCI Thesaurus)
C0014876 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
TumorExtension,OtherStructures
Item
Other, specify
text
Item Group
Prior Treatment
Item
Prior adjuvant RT? (If yes, record below)
text
CL.41
Code List
Prior adjuvant RT? (If yes, record below)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
AdjuvantRTBeginDate
Item
Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
date
AdjuvantRTEndDate
Item
Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
date
RTTotalDose
Item
Total dose of Radiation Therapy (cGy)
double
Item
Prior Adjuvant Chemotherapy?
text
CL.42
Code List
Prior Adjuvant Chemotherapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed8
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Baseline Symptoms/"toxicity" Status
Comments
Item
COMMENTS
text
Item
CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
text
CL.43
Code List
CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
CL Item
Anorexia (anorexia)
CL Item
Chest Pain (chest pain (non-cardiac and non-pleuritic))
CL Item
Constipation (constipation)
CL Item
Diarrhea For Patients Without Colostomy (diarrhea (patients without colostomy))
CL Item
Dry Skin (dry skin)
CL Item
Dyspnea (dyspnea (shortness of breath))
CL Item
Fatigue (fatigue (lethargy, malaise, asthenia))
CL Item
Infection Without Neutropenia (infection (without neutropenia))
CL Item
Nausea (nausea)
CL Item
Pruritus (pruritus)
CL Item
Rash/desquamation (rash / desquamation)
CL Item
Vomiting (vomiting)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Item
CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.44
Code List
CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Pain (Pain)
CL Item
Dermatology/skin (Dermatology/Skin)
CL Item
Pulmonary (Pulmonary)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Infection (Infection)
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
Item Group
Concomitant Medications
AgentName
Item
Agent Name (generic or trade name)
text
Item Group
Unnamed9
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Other Major Medical Problems
PatientMedicalConditionDate
Item
Date Documented (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
PatientMedicalConditionText
Item
Condition (e.g. diabetes)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
PatientHistoryText
Item
Other Relevant Details (e.g. insulin treatment)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Comments
Comments
Item
COMMENTS
text
Item Group
Investigator Signature
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
Ccrr Module For Form 1 - Eligibility Checklist And Initial Evaluation
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